What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study.

INTRODUCTION: Previous studies have found differences in the communication of safety issues among medicines regulatory agencies. OBJECTIVES: To explore (1) to what extent regulators' opinions regarding the need to communicate safety issues related to sodium-glucose cotransporter-2 (SGLT2) inhibitors might be influenced by their concern about the safety issue, and (2) whether regulators' concerns might be influenced by certain characteristics of the safety issue or by the demographic and professional characteristics and attitudes of the regulators. METHODS: An online cross-sectional survey study with a rating-based conjoint analysis among clinical and pharmacovigilance assessors from the EU regulatory network was performed between April and June 2021. Regulators were invited by email, and participants were asked about their level of concern and their opinion regarding the need to communicate about 12 scenarios defined by four characteristics: adverse drug reaction, source of information, causality, and frequency. The outcomes for the first objective were to update the summary of product characteristics (SmPC; yes/no) and to send direct healthcare professional communications (DHPC; yes/no). The determinant was regulators' level of concern (range 0-100%). The outcome of the second objective was regulators' level of concern, and the determinants were the characteristics of the safety issue, demographic and professional characteristics, and attitudes of the regulators (beliefs about medicines and risk perception). RESULTS: A total of 222 regulators completed the survey (64% women; mean age 46 ± 10 years). Depending on the scenario, 54-94% and 25-74% of the participants would update the SmPC or send a DHPC, respectively. The participants' level of concern influenced their opinions regarding the need to update the SmPC and send a DHPC (odds ratio (OR) 13.0; 95% confidence interval (CI) 7.8-21.7 and OR 13.6; 95% CI 9.5-19.2, respectively, for every 10% increase in the level of concern). All characteristics of the safety issue influenced the level of concern. Younger participants, women, and those working for Eastern European agencies had a higher level of concern than older participants, men, and those working in other regions. Beliefs about medicines and general risk perception also influenced their concern. CONCLUSIONS: The opinion regarding the need to communicate safety issues was influenced by the concern of regulators. Regulators' concern was influenced by the characteristics of the safety issue, demographic characteristics, and attitudes. Diverse groups of experts regarding such factors would ensure that various views are incorporated in risk communication decisions.

Differences in medication beliefs between pregnant women using medication, or not, for chronic diseases: a cross-sectional, multinational, web-based study.

OBJECTIVES: To assess whether medication beliefs differ between women who use or not use medication for their somatic chronic diseases during pregnancy and whether this association varies across diseases. DESIGN: Cross-sectional web-based survey. SETTING: Multinational study in Europe. PARTICIPANTS: Pregnant women or women with children less than 1 year old from European countries and with asthma, allergy, cardiovascular, rheumatic diseases, diabetes, epilepsy and/or inflammatory bowel diseases (IBD). PRIMARY AND SECONDARY OUTCOME MEASURE: Differences in scores of the Beliefs about Medicines Questionnaire (BMQ). RESULTS: In total, 1219 women were included (ranging from 736 for allergy to 49 for IBD). Women using medication for their chronic disease (n=770; 63%) had higher scores on the BMQ subscales necessity (16.6 vs 12.1, p<0.001) and benefits (16.2 vs 15.4, p<0.001), and lower values on the subscales overuse (12.5 vs 13.1; p=0.005) and harm (9.8 vs 10.7, p<0.001) than women not using medication. No significant differences were shown for the concerns subscale (12.5 vs 12.3, p=0.484). Beliefs varied somewhat across diseases but in general more positive beliefs among women using medication were shown. Epilepsy was the disease where less differences were observed between women using and not using medication. CONCLUSION: Women's beliefs were associated with medication use during pregnancy with only small differences across the diseases. Knowing pregnant women's beliefs could help identify women who are reluctant to use medication and could guide counselling to support making well-informed treatment decisions.

Differences in Importance Attached to Drug Effects Between Patients With Type 2 Diabetes From the Netherlands and Turkey: A Preference Study.

Objective: The aim of this study was to compare the importance that patients with type 2 diabetes mellitus from the Netherlands and Turkey attach to certain drug effects of oral anti-diabetic drugs. Methods: Data were collected through a cross-sectional survey containing demographic questions and a discrete choice experiment assessing preferences for oral anti-diabetic drugs. Adults from the Netherlands and Turkey were included if they had type 2 diabetes mellitus and had received a prescription of an oral anti-diabetic drug in the last 4 months. The oral anti-diabetic drugs in the discrete choice experiment were described in terms of six attributes: effects on HbA1c, cardiovascular diseases, weight change, gastrointestinal adverse drug events hypoglycemic events, and bladder cancer. Multinomial logit models with country as an interaction factor were fitted. Results: In total, 381 patients were included, 199 from the Netherlands and 182 from Turkey. Patients' preferences toward drug effects varied between the countries. Turkish patients attached the highest importance to reducing the risk of cardiovascular diseases (relative weight: 0.51, 95% CI 0.45-0.55), followed by reducing hypoglycemic events (relative weight: 0.16, 95% CI 0.11-0.22), and reducing gastrointestinal adverse drug events (relative weight: 0.11, 95% CI 0.07-0.18). Patients from the Netherlands attached the highest importance to gastrointestinal ADEs (relative weight: 0.22, 95% CI 0.14-0.39), followed by reducing hypoglycemic events (relative weight: 0.22, 95% CI 0.16-0.25), and reducing the risk of cardiovascular diseases (relative weight: 0.20, 95% CI 0.13-0.23). Conclusion: Patient preferences may differ across countries. Such differences should be acknowledged in regulatory decisions and clinical practice.